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Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC


Phase 2/Phase 3
20 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC


Inclusion Criteria:



1. Patients who have provided written informed consent

2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent
stage Ta, grade G1-G2 and satisfy both of the following criteria:

- The maximum number of tumors is 5.

- Each tumor diameter: ≤ 3.5 cm.

3. Age: ≥20 years old at enrollment.

4. The functions of the major organs are adequate, and the following test value criteria
are satisfied:

- Neutrophil count ≥1,500/μL

- Platelet count ≥10×10^4/μL

- Hemoglobin ≥10 g/dL

Exclusion Criteria:

1. Patients with a single, primary bladder cancer of <0.5 cm.

2. Patients with CIS lesions in the bladder or a history thereof.

3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease.

4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC
(duration between the last TURBT and cystoscopic confirmation of the present
recurrence is within 4 months).

5. Patients without at least a three-month cystoscopically confirmed recurrence-free
interval between the last TURBT and the time of study screening

6. Patients having a bladder tumor with a histological diagnosis other than urothelial
carcinoma of the bladder or a history thereof.

7. Patients who had been administered EO9 in the past.

8. Patients who had been administered any other investigational drug within the past 30
days.

9. Patients having a medical condition that would make it unsafe for them to undergo
TURBT under general or spinal anesthesia.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Yoshihiro Nambu, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Nippon Kayaku Co.,Ltd.

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

A9EO9201

NCT ID:

NCT01475266

Start Date:

November 2011

Completion Date:

April 2013

Related Keywords:

  • Bladder Cancer
  • Bladder Cancer
  • NMIBC
  • TURBT
  • Apaziquone
  • EOquin
  • Immediate instillation
  • Urinary Bladder Neoplasms

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